FDA grants Ascendis accelerated approval – Yuviwel cleared for achondroplasia

The U.S. Food and Drug Administration granted accelerated approval to Ascendis Pharma’s once‑weekly TransCon CNP (now Yuviwel) for children aged two and older with achondroplasia. The decision was based on improved annualized growth velocity (AGV) seen in pivotal data; Ascendis must now confirm clinical benefits in post‑marketing trials. Company statements and analyst notes indicate the drug will compete directly with BioMarin’s daily injection, Voxzogo, and Ascendis expects physician availability in the second quarter.